The Edwards Lifesciences, PARTNER II Trial, is a non-inferiority study of patients with severe symptomatic calcific aortic valve stenosis. The trial is designed to evaluate the safety and efficacy of the next-generation Edwards SAPIEN XT transcatheter heart valve (THV).
Cohort A of The PARTNER II Trial is designed for patients considered to be at intermediate risk* for traditional open-chest surgical aortic valve replacement (AVR)—a lower risk profile than patients studied in Cohort A of The PARTNER Trial.
Patients from this group will be evaluated to see if they have appropriate access for the transfemoral approach. If the patient is deemed appropriate they will be randomized 1:1 for TAVR via transfemoral delivery with the Edwards SAPIEN XT THV or traditional open-chest AVR.
For patients who are assessed as not being suitable for transfemoral access, they will be randomized 1:1 for TAVR via either transapical or transaortic delivery** or have traditional open-chest AVR.
Cohort B of The PARTNER II Trial is designed for patients with a higher risk profile who are deemed inoperable and therefore are not candidates for traditional open-chest AVR. In this cohort, candidates for TAVR via transfemoral delivery will be randomized 1:1 to receive either the Edwards SAPIEN XT THV or the first-generation Edwards SAPIEN THV. Those not eligible for transfemoral access may be followed in one of two registries until the enrollment of these registries complete.
* Intermediate risk is STS≥4
** Decision based on physician assessment